Interactions between physicians and industry have the potential to benefit both physicians and patients by advancing medical knowledge and improving patient care. However, sometimes the goals and interests of industry may be at odds with a physician’s professional and legal obligations. The resulting ethical dilemmas or conflicts of interest can have the potential to adversely affect the physician-patient relationship and public trust in the profession.

The Conflicts of Interest and Industry Relationships policy, and this companion Advice document, do not intend to discourage appropriate physician-industry interactions. Instead, they aim to assist physicians in managing their relationships with industry, and to set out relevant expectations and guidance in doing so.

General

What steps do I take when I identify a conflict of interest?

In general, it is best practice to avoid conflicts of interest altogether (e.g., by withdrawing or removing oneself from the situation). Where this is not possible, conflicts of interest may be appropriately managed through disclosure to patients, making them aware of alternatives, and offering reassurance that the patient’s choice of an alternative will not affect the quality of care. It is important that any disclosure to the patient be full, frank, and timely. It is also best practice to document the details of disclosure and relevant outcomes in the patient’s medical record.

It is important to remember that any conflict must be resolved in the best interests of the patient and that you must be able to demonstrate that the patient’s best interests have been maintained at all times. You may also be expected to comply with relevant organizational policies or guidelines on managing conflicts of interest where you practise and/or conduct research.

The policy defines “conflict of interest” as involving primary and secondary interests. What are examples of these types of interests?

A physician’s primary interests are determined by their professional duties and vary according to the activity they are engaged in. For instance, a primary interest can be providing care in the patient’s best interests, conducting unbiased medical research, or fostering high-quality medical education. Patients, the public, research participants, and medical learners need to trust physicians to act in ways that are consistent with these primary interests.¹

Secondary interests can be a legitimate part of a physician’s practice but cannot be achieved at the expense of primary interests. They are most commonly thought of in terms of personal financial gain; however, they can also include the desire for professional advancement, recognition of personal achievement, or favours or financial advantage for family or friends.

How can I determine whether a primary interest is compromised by a secondary interest?

Whether a primary interest is compromised by a secondary interest is a matter of judgment and depends on the context. Relevant factors to consider in assessing the likelihood and seriousness of a conflict of interest can include:²

• Monetary value: the greater the value of the secondary interest, the more likely its actual or perceived influence.
• Scope (duration and depth) of a relationship: longer and closer associations can increase the risk.
• Authority and discretion in a role: certain roles (e.g., Principal Investigator) may afford more discretion and influence in making important decisions.
• Scope of consequences: conflicts that can impact many patient care decisions (e.g., developing clinical practice guidelines) may have more potential for harm.
• Extent of accountability: the availability of accountability measures can reduce the likelihood or severity of harm.

What circumstances are considered conflicts of interest under the Medicine Act, 1991?

Under Part IV of Ontario Regulation 114/94 under the Medicine Act, 1991, it is a conflict of interest for physicians to do any of the following:

1. Receive any benefit,³ directly or indirectly, from a supplier to whom the physician refers patients/specimens or who supplies medical goods or services to the physician’s patients.

Of note, the term “supplier” in O. Reg. 114/94 is broad and includes, among other things, pharmacists and all other regulated health professionals.

2. Rent premises to or from a supplier, except where the rent is normal for the area and the amount of rent is not related to the referral of patients to the landlord.
3. Sell or otherwise supply any drug, medical appliance, medical product, or biological preparation to a patient at a profit, except:
   • a drug that is necessary
     • for immediate treatment of the patient;
     • in an emergency; or
     • where the services of a pharmacist are not reasonably readily available; or
   • an allergy preparation sold or supplied for a price subject to limits.
4. Order a diagnostic or therapeutic service to be performed at a facility in which they or their family have a proprietary interest, unless the interest is disclosed in advance to the patient, or the facility is a publicly-traded corporation and not owned or controlled by the physician or a member of their family.

When disclosing to a patient the fact that you or a family member has a proprietary interest in a facility where a diagnostic or therapeutic service will be performed, it is important that, at a minimum, the notice is clearly written (e.g., a sign or a form).

How can I support medical students and postgraduate trainees in avoiding and managing conflicts of interest and interacting with industry appropriately?

Physicians are responsible for modelling professional and ethical behaviour for medical students and postgraduate trainees by acting in accordance with this policy. It is important that students and trainees do not feel pressured to interact with industry where they are uncomfortable doing so and that there be a safe and supportive environment for reporting any concerns around the interpretation of CPSO’s policy with physician supervisors/educators.

Industry Relationships in Clinical Practice

Why does the policy prohibit accepting gifts or inducements from industry?

A large body of empirical evidence demonstrates that accepting gifts or inducements of any value can influence and undermine a physician’s independent clinical judgment, even without the physician’s awareness.⁴ In general, it is best for physicians to exercise caution and critically evaluate any information provided by industry representatives. Physicians may sometimes find it helpful to meet with industry representatives to learn about a drug or medical device. However, it is important to keep in mind that industry representatives may be less likely to discuss a drug’s risks and adverse effects than its benefits, and this may lead to higher cost and lower quality prescribing.⁵

Physicians who work in organizations with policies prohibiting the acceptance of gifts and other inducements from industry are expected to comply with those policies.

What do I need to consider when distributing samples to patients?

Samples are primarily used by companies for marketing and promotional purposes, which can raise concerns about their influence on physician prescribing. Samples can be beneficial in certain circumstances (e.g., by allowing physicians to initiate therapy immediately, evaluate clinical performance of medication for a patient, and/or offset costs). However, they may not be the physician’s first choice of medication and may be more expensive than other medications, potentially leading to higher out-of-pocket costs for patients when samples run out.

You must consider the influence of samples on your prescribing and use clinical evidence for therapeutic decisions. This could include taking into account whether the sample is your first choice of treatment, whether you have reason to believe that the patient may struggle to afford or be unable to pay for the drug being prescribed, and whether there is a therapeutically equivalent alternative available at lower cost. If the sample is of a medication which the patient may use on a long-term basis, you may wish to consider discussing with the patient other options for obtaining medications if they are available, for example, through the Ontario Drug Benefit Program or other patient assistance programs.

The Advice to the Profession: Prescribing Drugs includes additional information for physicians about considering prescription drug costs.

Continuing Medical Education/Continuing Professional Development (CME/CPD)

Can students/trainees receive funds from industry to attend CME/CPD events?

Scholarships or other funds from industry may be used to allow undergraduate medical students or post-graduate trainees (including fellows) to attend CME/CPD events, as long as their academic institution selects the recipients of these funds.

What do I need to know related to unaccredited CME/CPD events?

In addition to the policy expectations for physicians who organize, present at, or attend unaccredited CPD/CME event, the National standard for support of accredited CPD activities Element 7 specifies that unaccredited CME/CPD events cannot take place at times and locations that interfere or compete with accredited CME/CPD activities and cannot be listed or included within activity agendas, programs or calendars of events (preliminary and final).

Physicians attending informal or non-accredited learning activities with industry involvement will need to approach these activities with caution due to a higher likelihood that such events are promotional in nature.

Consultation/Advisory Boards and Industry-Sponsored Research

What do I need to be aware of when serving in a consultant or advisory role for industry?

It is important to be attentive to the perception of bias when attending meetings and receiving remuneration. In these roles, as with any interaction with industry, it will be important for physicians to maintain their professional objectivity and independence in any work they perform.

While it is generally preferable to attend meetings in your geographic locale or those that form part of a meeting that you would normally attend, factors such as the remoteness of your location and the availability of virtual meetings can be taken into consideration. As noted in the policy, compensation must be reasonable and commensurate with the services provided.

What do I need to know when participating in industry-sponsored research?

While research involving human participants can result in collective benefits for society at large, there may be little to no direct benefit to individual participants. Research can pose various risks to individuals and impact vulnerable populations. When conducting industry-sponsored research, it is important that the primary objective of research be the advancement of the health of the public rather than the private benefit of either physicians or industry.

Physicians participating in industry-sponsored research must continue to meet expectations of all physicians participating in research generally. The principles and responsibilities articulated in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) are broadly applicable to physicians conducting research involving human participants.⁶ This includes seeking approval from a research ethics board (REB).

When conducting research with First Nations, Inuit, and Métis peoples, physicians may refer to Chapter 9 of the TCPS-2 and consider the application of the First Nations Principles of OCAP.

What information needs to be disclosed to patients for consent to be informed?

A physician’s duty towards research participants can be greater than their duty towards a patient because of the experimental nature of the research and the potential lack of corresponding therapeutic benefit to the research participant. Therefore, obtaining consent for participation in research can require a higher level of disclosure than what is typically required when obtaining consent to treatment.

The TCPS-2 requires researchers to provide prospective participants full disclosure of all information necessary for making an informed decision to participate in a research project. Chapter 3 outlines the information that may be required, including:

• the identities of the researcher and the funder or sponsor; and
• information concerning any real, potential or perceived conflicts of interest on the part of the researchers, their institutions, or the research sponsors.

Can I respond to industry requests for patient contact information?

Physicians must comply with the Personal Health Information Protection Act, 2004 (PHIPA) when collecting, using, or disclosing personal health information (PHI). Under s. 44(1) of PHIPA, physicians may disclose PHI to researchers where certain conditions are met. However, s. 44(6)(e) prohibits the researcher from contacting those patients, either directly or indirectly, unless the physician has obtained the patient’s consent to be contacted by the researcher.⁷

Endnotes

^1. Lo, Bernard and Field, Marilyn J. Conflict of Interest in Medical Research, Education, and Practice. (2009) Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice.

^2. Lo, Bernard and Field, Marilyn J. Conflict of Interest in Medical Research, Education, and Practice. (2009)

^3. “Benefit” is expansively defined in s. 15 of O. Reg. 114/94 under the Medicine Act, 1991 and includes gifts, advantages, or “emolument” (a salary, fee, or profit from employment).

^4.For examples, please see the following articles:

• Katz, Dana, Caplan, Arthur, & Merz, Jon. (2003, June 1). All Gifts Large and Small: Toward an Understanding of Pharmaceutical Gift Giving. University of Pennsylvania Scholarly Commons – Center for Bioethics Papers.
• Spurling, GK, et al. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing: A Systematic Review. (2010). PLoS Med. 7(10), e1000352.
• Brax H, et al. Association between physicians' interaction with pharmaceutical companies and their clinical practices: A systematic review and meta-analysis. (2017) PLoS One. 12(4):e0175493.

^5.Spurling, GK, et al.

^6.Stirrett v Cheema,Barker v. Barker, 2020 ONSC 3746, at para. 1171.

^7. See the Canadian Medical Protective Association, Clinical research, Medical-legal issues to consider with clinical research contracts, and Physicians and research: Understanding the legal, ethical, and professional obligations. Information and Privacy Commissioner of Ontario, Consent and your personal health information and Use and Disclosure of Personal Health Information for Broader Public Health Purposes.